Determination That QMIIZ (Meloxicam) Orally Disintegrating Tablets, 7.5 Milligrams and 15 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 9156-9157 [2024-02710]
Download as PDF
<![CDATA[
9156
Federal Register / Vol. 89, No. 28 / Friday, February 9, 2024 / Notices
services are consistent with efficiency,
economy, and quality of care. CMS will
collect this data to ensure that VBP
programs adopted by States continue to
meet these standards. Form Number:
CMS–10722 (OMB control number:
0938–1385); Frequency: Yearly; Affected
Public: State, Local, or Tribal
Governments; Number of Respondents:
51; Total Annual Responses: 51; Total
Annual Hours: 306. (For policy
questions regarding this collection
contact Abraham Weinschneider at 410–
786–5688.)
4. Type of Information Collection
Request: Extension without change of a
currently approved collection; Title of
Information Collection: Limitations on
Provider Related Donations and Health
Care Related Taxes, Medicaid and
Supporting Regulations in 42 CFR
433.68 through 433.74; Use: States may
elect to submit a waiver to CMS for the
broad based and/or uniformity
requirements for any health care related
tax program which does not conform to
the broad based and uniformity
requirements. It is also the
responsibility of each State to
demonstrate that their tax program(s) do
not violate the hold harmless provision.
For a waiver to be approved and a
determination that the hold harmless
provision is not violated, States must
submit written documentation which
satisfies the regulatory requirements.
Without this information, the amount of
FFP (Federal financial participation)
payable to a State cannot be correctly
determined. Form Number: CMS–R–148
(OMB control number: 0938–0618);
Frequency: Quarterly and occasionally;
Affected Public: State, Local, or Tribal
Governments; Number of Respondents:
50; Total Annual Responses: 40; Total
Annual Hours: 3,200. (For policy
questions regarding this collection
contact Stuart Goldstein at 410–786–
0694.)
William N. Parham, III
Director, Division of Information Collections
and Regulatory Impacts, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2024–02662 Filed 2–8–24; 8:45 am]
ddrumheller on DSK120RN23PROD with NOTICES1
BILLING CODE 4120–01–P
VerDate Sep<11>2014
17:20 Feb 08, 2024
Jkt 262001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–P–4279]
Determination That QMIIZ (Meloxicam)
Orally Disintegrating Tablets, 7.5
Milligrams and 15 Milligrams, Were Not
Withdrawn From Sale for Reasons of
Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) has
determined that QMIIZ (meloxicam)
Orally Disintegrating Tablets, 7.5
milligrams (mg) and 15 mg, were not
withdrawn from sale for reasons of
safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for QMIIZ
(meloxicam) Orally Disintegrating
Tablets, 7.5 mg and 15 mg, if all other
legal and regulatory requirements are
met.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Nikki Mueller, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6280,
Silver Spring, MD 20993–0002, 301–
796–3507, Nicole.Mueller@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Section
505(j) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
355(j)) allows the submission of an
ANDA to market a generic version of a
previously approved drug product. To
obtain approval, the ANDA applicant
must show, among other things, that the
generic drug product: (1) has the same
active ingredient(s), dosage form, route
of administration, strength, conditions
of use, and (with certain exceptions)
labeling as the listed drug, which is a
version of the drug that was previously
approved, and (2) is bioequivalent to the
listed drug. ANDA applicants do not
have to repeat the extensive clinical
testing otherwise necessary to gain
approval of a new drug application
(NDA).
Section 505(j)(7) of the FD&C Act
requires FDA to publish a list of all
approved drugs. FDA publishes this list
as part of the ‘‘Approved Drug Products
With Therapeutic Equivalence
Evaluations,’’ which is known generally
as the ‘‘Orange Book.’’ Under FDA
regulations, drugs are removed from the
list if the Agency withdraws or
suspends approval of the drug’s NDA or
ANDA for reasons of safety or
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
effectiveness or if FDA determines that
the listed drug was withdrawn from sale
for reasons of safety or effectiveness (21
CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
QMIIZ (meloxicam) Orally
Disintegrating Tablets, 7.5 mg and 15
mg, are the subject of NDA 211210, held
by TerSera Therapeutics LLC (TerSera),
and initially approved on October 19,
2018. QMIIZ is a non-steroidal antiinflammatory indicated for
osteoarthritis in adults, rheumatoid
arthritis in adults, and pauciarticular or
polyarticular course juvenile
rheumatoid arthritis in pediatric
patients who weigh greater than or
equal to 60 kilograms.
In a letter dated March 24, 2021,
TeraSera notified FDA that QMIIZ
(meloxicam) Orally Disintegrating
Tablets, 7.5 mg and 15 mg, were being
discontinued, and FDA moved the drug
product to the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book.
Pharmobedient Consulting submitted
a citizen petition dated September 27,
2023 (Docket No. FDA–2023–P–4279),
under 21 CFR 10.30, requesting that the
Agency determine whether QMIIZ
(meloxicam) Orally Disintegrating
Tablets, 7.5 mg and 15 mg, were
withdrawn from sale for reasons of
safety or effectiveness.
After considering the citizen petition
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that QMIIZ (meloxicam)
Orally Disintegrating Tablets, 7.5 mg
and 15 mg, were not withdrawn for
reasons of safety or effectiveness. The
petitioner has identified no data or other
information suggesting that QMIIZ
(meloxicam) Orally Disintegrating
Tablets, 7.5 mg and 15 mg, were
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of QMIIZ
(meloxicam) Orally Disintegrating
Tablets, 7.5 mg and 15 mg, from sale.
We have also independently evaluated
relevant literature and data for possible
postmarketing adverse events. We have
reviewed the available evidence and
determined that this drug product was
E:\FR\FM\09FEN1.SGM
09FEN1
Federal Register / Vol. 89, No. 28 / Friday, February 9, 2024 / Notices
not withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list QMIIZ (meloxicam)
Orally Disintegrating Tablets, 7.5 mg
and 15 mg, in the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book. The ‘‘Discontinued Drug Product
List’’ delineates, among other items,
drug products that have been
discontinued from marketing for reasons
other than safety or effectiveness.
ANDAs that refer to QMIIZ (meloxicam)
Orally Disintegrating Tablets, 7.5 mg
and 15 mg, may be approved by the
Agency as long as they meet all other
legal and regulatory requirements for
the approval of ANDAs. If FDA
determines that labeling for this drug
product should be revised to meet
current standards, the Agency will
advise ANDA applicants to submit such
labeling.
Dated: February 6, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–02710 Filed 2–8–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–0014]
Vaccines and Related Biological
Products Advisory Committee; Notice
of Meeting; Establishment of a Public
Docket; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments.
ACTION:
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Vaccines and Related
Biological Products Advisory
Committee (VRBPAC). The general
function of the committee is to provide
advice and recommendations to FDA on
regulatory issues. This meeting will be
held to discuss and make
recommendations on the selection of
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
17:20 Feb 08, 2024
Jkt 262001
strains to be included in the influenza
virus vaccines for the 2024 to 2025
influenza season. The meeting will be
open to the public.
DATES: The meeting will be held
virtually on March 5, 2024, from 9 a.m.
to 3:30 p.m. Eastern Time.
ADDRESSES: All meeting participants
will be heard, viewed, captioned, and
recorded for this advisory committee
meeting via an online teleconferencing
and/or video conferencing platform. The
online web conference meeting will be
available at the following link on the
day of the meeting: https://
youtube.com/live/Wf0aE32DPKc.
Answers to commonly asked
questions about FDA advisory
committee meetings may be accessed at:
https://www.fda.gov/Advisory
Committees/AboutAdvisoryCommittees/
ucm408555.htm. FDA is establishing a
docket for public comment on this
meeting. The docket number is FDA–
2024–N–0014. The docket will close on
March 4, 2024. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
March 4, 2024. Comments received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
timely if they are received on or before
that date.
Comments received on or before
February 26, 2024, will be provided to
the committee. Comments received on
or after February 26, 2024, and by
March 4, 2024, will be taken into
consideration by FDA. In the event that
the meeting is cancelled, FDA will
continue to evaluate any relevant
applications or information, and
consider any comments submitted to the
docket, as appropriate.
You may submit comments as
follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
9157
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2024–N–0014 for ‘‘Vaccines and Related
Biological Products Advisory
Committee (VRBPAC); Notice of
Meeting; Establishment of a Public
Docket; Request for Comments.’’
Received comments, those filed in a
timely manner (see ADDRESSES), will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
E:\FR\FM\09FEN1.SGM
09FEN1
]]>Agencies
[Federal Register Volume 89, Number 28 (Friday, February 9, 2024)]
[Notices]
[Pages 9156-9157]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-02710]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-P-4279]
Determination That QMIIZ (Meloxicam) Orally Disintegrating
Tablets, 7.5 Milligrams and 15 Milligrams, Were Not Withdrawn From Sale
for Reasons of Safety or Effectiveness
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) has
determined that QMIIZ (meloxicam) Orally Disintegrating Tablets, 7.5
milligrams (mg) and 15 mg, were not withdrawn from sale for reasons of
safety or effectiveness. This determination will allow FDA to approve
abbreviated new drug applications (ANDAs) for QMIIZ (meloxicam) Orally
Disintegrating Tablets, 7.5 mg and 15 mg, if all other legal and
regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Nikki Mueller, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6280, Silver Spring, MD 20993-0002, 301-
796-3507, [email protected].
SUPPLEMENTARY INFORMATION: Section 505(j) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of
an ANDA to market a generic version of a previously approved drug
product. To obtain approval, the ANDA applicant must show, among other
things, that the generic drug product: (1) has the same active
ingredient(s), dosage form, route of administration, strength,
conditions of use, and (with certain exceptions) labeling as the listed
drug, which is a version of the drug that was previously approved, and
(2) is bioequivalent to the listed drug. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
Section 505(j)(7) of the FD&C Act requires FDA to publish a list of
all approved drugs. FDA publishes this list as part of the ``Approved
Drug Products With Therapeutic Equivalence Evaluations,'' which is
known generally as the ``Orange Book.'' Under FDA regulations, drugs
are removed from the list if the Agency withdraws or suspends approval
of the drug's NDA or ANDA for reasons of safety or effectiveness or if
FDA determines that the listed drug was withdrawn from sale for reasons
of safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (Sec. 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
QMIIZ (meloxicam) Orally Disintegrating Tablets, 7.5 mg and 15 mg,
are the subject of NDA 211210, held by TerSera Therapeutics LLC
(TerSera), and initially approved on October 19, 2018. QMIIZ is a non-
steroidal anti-inflammatory indicated for osteoarthritis in adults,
rheumatoid arthritis in adults, and pauciarticular or polyarticular
course juvenile rheumatoid arthritis in pediatric patients who weigh
greater than or equal to 60 kilograms.
In a letter dated March 24, 2021, TeraSera notified FDA that QMIIZ
(meloxicam) Orally Disintegrating Tablets, 7.5 mg and 15 mg, were being
discontinued, and FDA moved the drug product to the ``Discontinued Drug
Product List'' section of the Orange Book.
Pharmobedient Consulting submitted a citizen petition dated
September 27, 2023 (Docket No. FDA-2023-P-4279), under 21 CFR 10.30,
requesting that the Agency determine whether QMIIZ (meloxicam) Orally
Disintegrating Tablets, 7.5 mg and 15 mg, were withdrawn from sale for
reasons of safety or effectiveness.
After considering the citizen petition and reviewing Agency records
and based on the information we have at this time, FDA has determined
under Sec. 314.161 that QMIIZ (meloxicam) Orally Disintegrating
Tablets, 7.5 mg and 15 mg, were not withdrawn for reasons of safety or
effectiveness. The petitioner has identified no data or other
information suggesting that QMIIZ (meloxicam) Orally Disintegrating
Tablets, 7.5 mg and 15 mg, were withdrawn for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of QMIIZ (meloxicam) Orally Disintegrating
Tablets, 7.5 mg and 15 mg, from sale. We have also independently
evaluated relevant literature and data for possible postmarketing
adverse events. We have reviewed the available evidence and determined
that this drug product was
[[Page 9157]]
not withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list QMIIZ (meloxicam)
Orally Disintegrating Tablets, 7.5 mg and 15 mg, in the ``Discontinued
Drug Product List'' section of the Orange Book. The ``Discontinued Drug
Product List'' delineates, among other items, drug products that have
been discontinued from marketing for reasons other than safety or
effectiveness. ANDAs that refer to QMIIZ (meloxicam) Orally
Disintegrating Tablets, 7.5 mg and 15 mg, may be approved by the Agency
as long as they meet all other legal and regulatory requirements for
the approval of ANDAs. If FDA determines that labeling for this drug
product should be revised to meet current standards, the Agency will
advise ANDA applicants to submit such labeling.
Dated: February 6, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-02710 Filed 2-8-24; 8:45 am]
BILLING CODE 4164-01-P
